X-Ray Verified Accuracy of the proGAV Verification Instrument (X-AMIN)

January 26, 2017 updated by: Aesculap, Inc.

X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument

This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Madeira, California, United States, 93636-8762
        • Valley Children's Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hydrocephalus patients implanted with proGAV shunt requiring adjustment

Description

Inclusion Criteria:

  • Implanted with proGAV Requiring adjustment Implant must be palpable under the skin

Exclusion Criteria:

  • Unwilling to consent Implanted within 7 days of inclusion visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.
Time Frame: 1day
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-1106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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